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www.biopharminternational.com Partnerships for Outsourcing eBook May 2023 BioPharm International ® 25 Fill/Finish for pharmaceutical companies and their CDMO part- ners developing new vaccines for the next pandemic. Key stakeholders—whether investors, governments, or the general public—now have high expectations about what the industr y is capable of. As a result, there is greater pressure not just on pharmaceutical companies, but on the partners, they rely on for fill/ finish and other manufacturing processes to match their COVID-19 achievements in future. Developers and their partners must reflect on what they got right and what went wrong during the vaccine drive over the past year to ensure they are well-pre- pared for future wide-scale drug developments. Understanding the challenges As typically parenteral drug products, vaccines must be processed, filled, and finished in a stringent sterile environment to safeguard doses from microbial or foreign-body contamination that could have harm- f ul effects for end-patients. Infrastructure is vital to achieving the required level of sterile integrity. This posed several challenges for the developers of COVID-19 vaccines, undermining their efforts to de- liver their discoveries to the market. The key challenges they faced included: • Finding capacity—A major issue that needed to be overcome was the sourcing of capacity at short notice. There is limited global availabil- it y of ready-to-use ster i le f i l l i ng i n f ra st r uc- t u re i n nor m a l cond it ion s; du r i ng t he pa n- demic, it was at a premium. Moreover, few drug developers had aseptic f i l l/f inish capacit y of their own ready for them to use to manufacture their vaccines at the required volumes, nor did t hey have t he resou rces a nd t i me to ex pa nd their existing capability. CDMOs with the nec- essar y sterile filling capacit y already in place stepped in to support drug developers and en- sure there were no delays in delivering the new vaccines to the public. • Upgrading non-sterile filling—One option ex- plored by both pharmaceutical companies and t heir CDMO par tners to address t he capacit y shortage was to upgrade non-sterile filling lines with restricted access barrier systems (RABS) and other technologies to achieve sterile integrity. However, upgrades were not just challenging because of the financial cost. Space constraints made retrofitting equipment difficult. Moreover, many companies may not have been able to have a line out of operation for the time required to complete the upgrades. • Prioritizing projects—Another challenge faced by both drug developers and their outsourcing partners during the pandemic involved prioritiz- ing projects. While the COVID-19 vaccines took the lion's share of attention, investment, and manufacturing capacity, they weren't the only important development projects being under- taken by the industr y. Pharma companies and CDMOs alike had to work together to prioritize key projects to ensure both the COVID-19 vac- cines and other treatments could be commercial- ized and launched quickly and effectively. • Reconciling aseptic integrity and production efficiency—Both pharmaceutical companies and their CDMO partners had to find solutions to en- sure stringent sterile integrity was maintained during filling while also optimizing manufactur- ing output. Traditionally, fill/finish equipment has to be cleaned and sterilized to ensure that no cont a m i n at ion t a kes pl ace —a t i me-con- suming and costly process. At the height of the pandemic, this undermined the productivity of limited aseptic filling capacity. As a result, alter- native processes had to be found that achieved the same stringent quality standards while re- ducing downtime, such as the greater use of sin- gle-use technologies (SU Ts) that don't require cleaning between uses. • Controlling the environment to ensure stability— Many COVID-19 vaccines had specific, strict tem- perature control requirements as low as minus 90 ℃ to ensure t hey remained stable during processing, storage, and transit. This was a chal- lenge for both vaccine developers and CDMOs to maintain throughout the manufacturing, filling, and transport process. Judging by the success of the COVID-19 vaccine roll- out, it is safe to say that the pharmaceutical industry found ways to overcome many of these issues to deliver their products on time. Through collaboration with CDMOs, vaccine develop- ers were able to source the sterile filling capacity they needed with minimal delay, instead of having to wait months or years to build their own dedicated lines. Pharma companies and their CDMO partners need to ensure their fill/finish lines comply with the requirements of Annex 1.